FLOTEC

Additional Manufacturer Narrative

THE DEVICE WAS RECIEVED AND EVALUATED USING RMA19-065. THE EVALUATION IMMEDIATELY NOTED A STRIPPED SCREW HEAD ON THE SCREW HOLDING THE FLOWMETER SECTION TOGETHER. IT IS UNKNOWN IF THIS WAS STRIPPED DURRING OR AFTER THE LAST OFFICIAL SERVICE OF THE DEVICE. FLOTEC'S RMA TECH WAS IMMEIATELY ABLE TO IDENTIFY THE PROBLEM, AS SUCH IT SEEMS UNLIKELY THAT A STRIPPED SCREW WOULD MAKE IT THROUGH THE RMA PROCESS WITHOUT BEING REPLACED. THE DEVICE WILL NOT BE SERVICED OR RETURNED. - ATTACHMENT: [STRIPPED SCREW ON FM.PNG]

Description of Event or Problem

FAMILY: FLOPAC; PN: FP1XX006700P7; SN: (B)(4). DATE OF EVENT: (B)(6) 2019; TIME: 11:30 AM; LOCATION: USER FACILITY. REPORT BY FACILITIES MANAGER, I RECEIVED A CALL FROM (NAME REMOVED) TODAY AND HE MADE ME AWARE THAT A FLOTEC REGULATOR ON A MEDICAL OXYGEN E SIZE CYLINDER BLEW UP WHILE IN USE ON A PATIENT. HE DESCRIBED THAT THE TOP OF THE REGULATOR BLEW OFF AND SMALL STEEL BEARINGS ACTED LIKE A SHOT GUN SHELL. HE STATED THAT THERE WERE NO INJURIES TO THE PATIENT OR ANY ONE ELSE BUT THE FLOTEC UNIT DID EXPELL A CONSIDERABLE AMOUNT OF OXYGEN TO THE PATIENT THROUGH THE NASAL CANNULA TO THE POINT THAT IT WAS BLOWING HER HAIR BACK. REPORT BY DISTRIBUTOR: RT WITH PATIENT WHEN THE INCIDENT HAPPENED NOTICED THAT THE REGULATOR WAS SUPER EASY TO TURN (KNOB). THE PATIENT HAD A LARGE EXTENDED BURST OF OXYGEN THROUGH THE CANULA. THE PATIENT'S NOSTRILS FLARED OUT AND HAIR WAS BLOWING UP. THE LPM NOB (KNOB) CAME OFF THE REGULATOR. THERAPIST WAS ABLE TO MINIMIZE THE DISCHARGE IF TE=HE INSIDE BEARINGS AND SPRINGS. NO INJURIES REPORTED. FLOTEC WAS NOTIFIED OF THE INCIDENT ON 2019-04-15.